21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia (NCT06613997) | Clinical Trial Compass
Not Yet RecruitingPhase 3
21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia
100 participantsStarted 2025-01-15
Plain-language summary
Our aim is to test the hypothesis that a 3-week course of albendazole 400 mg daily is safe and can progressively reduce Loa loa microfilarial densities in subjects with microfilaremia.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Consent informed, written, signed and dated
* Women or men aged 18 to 70 years inclusive
* Carrier of L. loa microfilaremia
* Body weight ≥ 40 kg and less than 90 kg
Exclusion Criteria:
* Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of albendazole placebo)
* Any vaccination within 4 weeks previous to this study
* Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
* Known immunosuppressive pathology (by self-report)
* Past or present history of neurological (including epilepsy) or neuropsychiatric disease
* Current treatment with ritonavir and/or rifampicin
* Use of cocaine or other drugs of abuse in the 72 hours preceding administration of the trial treatment, as determined by history during the medical interview
* Past or present history of liver, kidney or bone marrow failure
* ALAT transaminase level ≥ 3 times the upper limit of normal (3N) according to laboratory standards
* Any condition, in the opinion of the investigator, that exposes the subject to undue risk
* Known intolerance to ALB or benzimidazole derivatives in general
* Subjects who donated blood in the previous 8 weeks to study entry, with a standard volume (500 mL)
* On clinical examination…
What they're measuring
1
Tolerance of Albendazole 400mg/day in individuals with Loa loa microfilaremia
Timeframe: During the treatment (21 days) and 3 month after
2
Efficacity of Albendazole 400mg/day in individuals with Loa loa microfilaremia
Timeframe: During the treatment (21 days) and 6 months after
Trial details
NCT IDNCT06613997
SponsorProgramme National de Lutte contre l'Onchocercose, Republic of the Congo